← FDA DRUG APPROVALS

FDA ANDA · ANDA206486

MAGNESIUM SULFATE IN 5% DEXTROSE

magnesium sulfate heptahydrate

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA206486
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-07
LATEST ACTION
2016-03-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
MAGNESIUM SULFATE 1GM/100ML · INJECTABLE · INJECTION

Approval history

2016-03-07UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →